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Health product recall

Nellcor SpO2 Forehead

Starting date:
November 15, 2016
Posting date:
January 18, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-61812

Reason

This voluntary recall is being conducted due to a labeling error. The label indicates the product is latex-free, however, the headband component included with the forehead sensor does contain latex.

Affected products

Nellcor SpO2 Forehead

Lot or serial number

  • 161510095H
  • 161620089H
  • 161690203H
  • 161760132H
  • 161900091H
  • 161970090H
  • 162040107H
  • 162110103H
  • 162320191H
  • 162390212H

Model or catalog number

RS10

Companies

Manufacturer
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES